This Funding Opportunity Announcement (FOA) seeks research
grant applications designed to develop innovative ways of understanding
mental disorders through classifying patients in clinical studies on the
basis of experimental research criteria rather than traditional diagnostic
categories. This FOA stems from the NIMH Research Domain Criteria (RDoC)
project that is intended to further a long-range goal of contributing to
diagnostic systems as informed by research on genetics, neuroscience, and
behavior. The purpose of this FOA is to encourage applications to study
mechanisms that may cut across multiple traditional diagnostic categories.
Applications submitted in response to this FOA should be based upon RDoC
criteria (see http://www.nimh.nih.gov/research-funding/rdoc.shtml for the RDoC criteria developed to date). Five organizing domains have been
identified in the draft specification. These include Negative Valence Systems
(i.e., aversive motivational dimensions), Positive Valence Systems, Cognitive
Systems, Social Process Systems, and Arousal/Regulatory Systems. Consensus
workshops and guidance documents on Negative Valence Systems, Positive
Valence Systems, and Working Memory (subsidiary of Cognitive Systems) are to
have been completed by the time applications in response to this FOA are due,
and applications must focus on at least one of these three RDoC domains.
Interested applicants are encouraged to consult the NIMH RDoC web site (http://www.nimh.nih.gov/research-funding/rdoc.shtml)
for current information regarding these constructs.

Key Dates

Posted Date

August 10, 2011

Open Date (Earliest Submission Date)

September 20, 2011

Letter of Intent Due Date

September 20, 2011

Application Due Date(s)

October 20, 2011, by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

October 21, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

The NIMH Strategic Plan calls for the clarification of the
underlying causes of mental disorders across the life span, with efforts
towards integrating genetic, neurobiological, imaging, behavioral, and clinical
data. This FOA addresses Strategy
1.4 of the NIMH Strategic Plan: Develop, for research purposes, new ways of
classifying mental disorders based on dimensions of observable behavior and
neurobiological measures. NIMH has begun the implementation of Strategy 1.4 via
the Research Domain Criteria (RDoC) project. This project, developed by an
internal NIMH working group in conjunction with a small group of external
consultants, has created a framework and process with which to implement the
research classification system called for by Strategy 1.4. The essence of the
project is to identify organizing dimensions that cut across multiple disorders
as traditionally defined, and to promote research according to these dimensions
rather than to traditional diagnostic categories. Applications that focus
primarily on validating a DSM diagnostic category will NOT be considered
responsive to this funding opportunity. Rather, this FOA encourages projects
that are consistent with the organizing dimensions identified by the RDoC
project. The RDoC project aims to support development of an integrative
scientific literature that can inform future diagnostic systems which will be
based on genetics, neuroscience, and psychology. Five organizing domains
have been identified in the draft specification. These include Negative
Valence Systems (i.e., aversive motivational dimensions), Positive Valence
Systems, Cognitive Systems, Social Process Systems, and Arousal/Regulatory
Systems. Consensus workshops on Negative Valence Systems, Positive Valence Systems,
and Working Memory (subsidiary of Cognitive Systems) are to have been completed
by the time applications in response to this FOA are due, and applications must
focus on at least one of these three RDoC domains. Interested applicants are
encouraged to consult the NIMH RDoC web site (http://www.nimh.nih.gov/research-funding/rdoc.shtml)
for current information regarding these constructs.

This FOA invites submission of research project grant
applications that focus on explicating and validating the domains and their
subsidiary constructs that have resulted from RDoC consensus workshops.
Priority will be given to applications that evaluate relevant constructs via
convergent measurement across multiple units of analysis, and applications that
would elaborate aspects of the constructs that are underdeveloped. See the Specific Areas of Research Interest section, below, for illustrations.

Background
and Rationale

Currently, the diagnosis of mental disorders is based on
clinical observations and reports by patients, caregivers, parents, and
teachers. This approach, formalized in the Diagnostic and Statistical
Manual-III (DSM-III) in 1980 and refined in subsequent DSM versions, has served
to improve diagnostic reliability in clinical practice and research. The
diagnostic categories represented in the DSM-IV and the International
Classification of Diseases-10 (ICD-10), containing virtually identical disorder
codes, remain the consensus standard for diagnosis of mental disorders, and are
employed for insurance billing, U.S Food and Drug Administration requirements,
and other institutional uses. By default, DSM diagnoses have also become
standard for characterizing research participants in grant applications and
publications.

Its dominance notwithstanding, the DSM diagnostic scheme has
not assimilated recent breakthroughs in genetics and neuroscience. Most genetic
and neural circuit anomalies appear to link either with multiple DSM diagnostic
categories or with narrow subgroups within diagnoses. A questionable
assumption that the clusters of self-reported symptoms codified in the DSM
define unique and homogeneous disorders could be constraining advances in the
biology of mental illness. Consequently inadequate understanding of
pathophysiology would in turn hamper the development of better
treatments. Notwithstanding these difficulties, there is general
consensus at this time that the biology of mental illness is insufficiently
developed to support a classification scheme based on the integration of
genetics, neuroscience, and psychopathology. The purpose of the RDoC
project is to promote such integrative science so that advances in genomics, pathophysiology,
and psychology can substantially inform diagnosis.

The purpose of the initial phase of the RDoC project is to
promote research employing clinical subjects from multiple diagnostic groups
appropriate to the research question, in order to establish construct validity
for some proposed organizing dimensions of psychopathology. This is to be done
through research on brain-behavior relationships that integrates findings from
multiple scientific disciplines. It is hoped that in later stages of development,
measures of the integrated constructs can be developed for practical clinical
use.

Potential applicants should read the material at the RDoC
website (http://www.nimh.nih.gov/research-funding/rdoc.shtml).
This site contains a detailed description of the background, rationale, draft
matrix of domains and units of analysis, examples of potential research
applications, and results of workshops convened to generate consensus
specifications. In accord with the focus on integrative science, each RDoC
construct will map onto seven units of analysis: behavior, cells,
circuits, genes, molecules, physiology, and self-reports. Note that independent
variables may be selected from any of the units of analysis and would typically
include subjects from multiple diagnostic groups. Research plans should
incorporate dependent variables from at least two units of analysis to converge
upon the construct to be studied.

The RDoC project involves a series of consensus workshops,
one for each of the five organizing domains listed above. The purpose of each
workshop is to identify promising constructs within the domain, define each
construct (and its overlaps and differences from other constructs), and specify
elements at each of the units of analysis that converge on the construct. The
draft matrix entries represent elements (genes, molecules, circuit measures,
behavioral tasks, questionnaires, etc.) that have been vetted by the workshop
process and appear especially promising for inclusion in research plans.
Applicants may opt for other relevant measures where a strong justification can
be made.

This FOA invites applications to study constructs that have
been addressed by RDoC workshops, and thereby have a definition and list of
pertinent elements at each unit of analysis. The FOA also invites evaluation of
the continuity of adult RDoC constructs in child and adolescent populations,
and the adaptation or development of relevant measures for children. To date,
workshops have been completed for Negative Valence Systems and for Working
Memory (part of the Cognitive Processes domain). The relevant materials can be
found at the RDoC website under the heading “Workshop Proceedings,” no later
than June 20, 2011. A workshop for Positive Valence Systems is slated for June
20 and 21, 2011 and the relevant materials can be found on the RDoC website
under the heading “Workshop Proceedings” no later than July 15, 2011.
Applications may study constructs that are essentially related to the
constructs and circuits delineated in the RDoC matrix. For example, emotion
regulation is a construct that refers to dynamic regulation of threat-related
amygdala activity by the ventromedial prefrontal cortex, and so could be
reasonably related to the RDoC threat construct.

Examples of research projects that might be submitted under
this FOA include, but are not limited to:

Evaluation of the efficacy of one or more treatments for anxiety
symptoms in individuals along a distribution of hyper-reactive amygdalar
responses to threat stimuli

Evaluation of the association of DISC1 and DTNBP1 abnormalities
with working memory performance along a dimension of anxious or anhedonic mood
symptoms

Comparison of anterior insula and superior temporal cortex
activity along a dimension of emotional engagement in a sample with trauma
history

Evaluation of the relationship of subgenual cingulate activity
and serotonergic function along a dimension of emotional dysregulation

Evaluation of the relationship between measures of exaggerated
fear response, reports of overall distress and anxiety, and chronicity of
internalizing disorders

Evaluation of developmental delay in prefrontal cortical
thickness along a dimension of performance on a series of working memory tasks

Longitudinal studies of the extent to which a dimension of
relative hypo-reactivity to hyper-reactivity in responding to emotional cues is
predictive of the subsequent onset or exacerbation of mood/anxiety symptoms

Evaluation of the relationships between various types of
dysregulation in HPA axis activity and the formation of emotional memories for
pleasant and unpleasant material

Priority will be given to applications that have a
well-justified plan to include patients from multiple diagnostic groups
(including Not Otherwise Specified and forme fruste diagnoses) as appropriate
for explicating the dimensions and constructs of interest in the study design.
Studies that include patients from a single diagnostic group may also be
considered if there is a particularly strong justification for examining
constructs of interest within one diagnostic category. A defensible approach
might be to study all patients presenting themselves at a specialty clinic, e.g.,
mood disorders clinic, anxiety clinic, or psychotic disorders clinic,
regardless of whether they meet criteria for a particular DSM diagnosis.

Section II. Award Information

Funding Instrument

Grant

Application Types Allowed

New

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The NIMH intends to commit approximately $3,000,000 in FY
2012 to fund four to six grants in response to this FOA. The number of
awards is contingent upon NIH appropriations, and the submission of a
sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect
actual needs of the proposed project.

Award Project Period

Scope of the proposed project should determine the project
period. The maximum period is 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review unless
the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Research Strategy

The Research Strategy Section should include clear
descriptions of which constructs from the RDoC matrix are to be evaluated and
of the units of analyses from the RDoC matrix that are to be employed. It
should also include a justification for the selection of the particular RDoC
constructs and units of analysis to be evaluated.

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424
(R&R) Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD/PIs must include their eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

In order to expedite review, applicants are requested to
notify the NIMH Referral Office by email at NIMHReferral@mail.nih.gov when the
application has been submitted. Please include the FOA number and title, PD/PI
name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission
materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Does the project investigate organizing
dimensions of psychopathology that cut across multiple disorders as
traditionally defined? Does the project have potential to inform future
diagnostic systems based on genetics, neuroscience, and psychology? Does the
project have potential to explicate or validate one or more of the domains or
their subsidiary constructs that have been addressed to date by RDoC consensus
workshops, i.e., Negative Valence Systems, Working Memory, Positive Valence
Systems?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the project? If Early Stage Investigators or New Investigators,
or in the early stages of independent careers, do they have appropriate
experience and training? If established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed? Does the project pursue construct evaluation via convergent measurement across at least two units of
analysis? Does the application have a well-justified plan to include patients
from multiple diagnostic groups as appropriate for explicating the dimensions
and constructs of interest in the study design? If the study includes patients
from a single diagnostic group is there a particularly strong justification for
examining constructs of interest within one diagnostic category?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Conformity to RDoC Concepts

The committee will consider whether the proposed work
involves evaluation of RDoC constructs across at least two levels of analysis,
and via dimensional, rather than categorical, assessment methods.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NIMH, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds
with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of
review by the National Advisory Mental Health Council.l The following will be
considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants Policy
Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.